Press Release: Phadia first company to receive FDA clearance of recombinant allergen component tests

510(K) clearance covers 13 molecular allergen components.

 

Uppsala, June 20, 2011

Newly-available tests provide deepest clinical insight into peanut allergy, as well as allergies to cat dander, dust mite, Bermuda grass, ragweed, and fungi enabling a significant improvement in the clinical management of patients with suspected allergies.

Phadia, the global leader in allergy and autoimmunity diagnostics, today announced the FDA clearance of recombinant ImmunoCAP allergen components for marketing in the United States. The FDA clearance applies to all of Phadia’s instrument platforms.

Phadia was the first diagnostics company to introduce allergen component testing globally and the company will continue to lead and advance the understanding of allergen component testing and its clinical application. Today’s announcement highlights the continued leadership role that Phadia plays in the evolution of innovative allergy diagnostic tools to support improved patient care. The FDA clearance covers 13 components (9 recombinants and 4 natives) including peanut, cat, dust mite, Bermuda grass, the fungi Alternaria alternata and Ragweed. Phadia has a significant number of additional ImmunoCAP allergen component tests that will be submitted to FDA this year.

"There is a need for greater understanding of the risk of clinical reactions. Recent studies suggest that component testing will help allergy and immunology specialists assess the risk of clinical reactions. There is much to learn and the allergy and immunology community is in a perfect position to take the lead in helping to interpret information gained from allergen component test results," says Dr. Hugh A. Sampson, Professor of Pediatrics at the Mount Sinai School of Medicine and Director of the Jaffe Food Allergy Institute.

ImmunoCAP specific IgE blood tests are considered the assay of choice among specialists, and referenced and supported in over 4,000 scientific publications. Today more than 80 components are available in Europe; ImmunoCAP recombinant allergen components have been used for over 10 years and native components have been used for over 30 years.

David Esposito, President and General Manager of Phadia US, said, "Allergen component testing is the most important new technology in advancing the care of patients with allergies and asthma. By identifying the specific molecule within the allergen causing the allergic reaction, clinicians have more information than ever to enhance patient care. Allergen component test results have the potential to assess risk for reaction, explain symptoms due to cross reactivity and identify a more targeted approach for patients requiring immunotherapy. This can improve health outcomes, and provide patient allergy and asthma action plans that make meaningful improvements in quality of life."

Phadia has plans to accelerate its ongoing commitment to educate clinicians and patients on the use of ImmunoCAP allergy testing platform to support improved patient care. Phadia continues to reinforce a guidelines-based care approach with its education efforts and most recently began a significant education effort to clinicians on the recently released NIH Guidelines for the Diagnosis and Management of Food Allergy in the US. The NIH Guidelines highlights the advantages of ImmunoCAP specific IgE testing compared to other technologies by stating "the predictive values associated with clinical evidence of allergy for ImmunoCAP cannot be applied to other test methods."

Media Contact:

Ulf Bladin
VP Global Marketing, Corporate Communication, Scientific Affairs

Tel. +46-18 16 50 00
ulf.bladin@phadia.com

6/20/2011

As in all diagnostic testing, the diagnosis is made by the physican based on both test results and the patient history.